A Phase 2, Open-Label, Single-Agent, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Metastatic or Surgically Unresectable Urothelial Carcinoma Harboring FGF/FGFR Alterations - (FIGHT-201)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 263
- 试验地点
- 96
- 主要终点
- Objective Response Rate (ORR) in Participants With FGFR3 Mutations or Fusions on a CD Regimen
研究概览
简要总结
The purpose of this study is to evaluate the overall response rate (ORR) of pemigatinib as a monotherapy in the treatment of metastatic or surgically unresectable urothelial carcinoma harboring FGF/FGFR alterations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20 years and older in Japan
- •Histologically documented metastatic or surgically unresectable urothelial carcinoma; may include primary site from urethra, ureters, upper tract, renal pelvis, and bladder.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Life expectancy ≥ 12 weeks.
- •Radiographically measurable per RECIST v1.
- •Documented FGF/FGFR alteration and have either 1a) failed at least 1 previous treatment for their metastatic or surgically unresectable urothelial carcinoma (ie, chemotherapy, immunotherapy) or 1b) have not received chemotherapy due to poor ECOG status or 2) have insufficient renal function.
排除标准
- •Prior receipt of a selective FGFR inhibitor.
- •Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half-lives (whichever is shorter) before the first dose of study drug.
- •Inability or unwillingness to swallow pemigatinib or significant gastrointestinal disorder(s) that could interfere with the absorption, metabolism, or excretion of pemigatinib.
研究组 & 干预措施
Cohort A-ID (Intermittent Dose) Pemigatinib
Pemigatinib in subjects with FGFR3 mutations or fusions.
干预措施: pemigatinib (Drug)
Cohort A-CD (Continuous Dose) Pemigatinib
Pemigatinib in subjects with FGFR3 mutations or fusions.
干预措施: pemigatinib (Drug)
Cohort B Pemigatinib
Pemigatinib in subjects with other FGF/FGFR alterations.
干预措施: pemigatinib (Drug)
结局指标
主要结局
Objective Response Rate (ORR) in Participants With FGFR3 Mutations or Fusions on a CD Regimen
时间窗: up to 1138 days
ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) at any post-Baseline visit prior to first progressive disease (PD), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Response was based on review of scans by an independent centralized radiological review committee. Response was confirmed.
次要结局
- ORR in Participants With All Other FGF/FGFR Alterations(up to 1198 days)
- ORR in All Participants on an ID or CD Regimen in Combined Cohorts(up to 1198 days)
- Overall Survival(up to 1610 days)
- Duration of Response (DOR)(up to 1075 days)
- ORR in Participants With FGFR3 Mutations or Fusions on an ID Regimen(up to 817 days)
- Number of Participants With Any Treatment-emergent Adverse Event (TEAE)(up to approximately 25 weeks)
- Progression-free Survival (PFS)(up to 1138 days)